510(k) · Cleared
Recalled · Class II · 2012Greiner Vacuette Quickshield Complete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One North America, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 14, 2007 as substantially equivalent to K033478 (Greiner Bio-One Vacuette North America, 2003) and 2 other predicates after a 25-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 14, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K972404 (1997). 6 ancestors in all, the oldest K950159 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK972404 Vacutainer Brand Safety Blood Collection Assembly (Multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1997 · Recalled
- 2 generations backK982541 Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 &…Becton Dickinson Vacutainer Systems · 1998 · Recalled
- 1 generation backK033478 Vacuette Quickshield Safety Tube HolderGreiner Bio-One Vacuette North America · 2003
- This deviceK072320 Greiner Vacuette Quickshield CompleteGreiner Bio-One North America, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK233979 VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233979VACUETTE® QUICKSHIELD Complete (Plus)Greiner Bio-One North America, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972404 | Vacutainer Brand Safety Blood Collection Assembly (Multiple) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | 1 |
| −2 | K982541 | Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 | Becton Dickinson Vacutainer Systems | 1998 | 1 |
| −1 | K033478 | Vacuette Quickshield Safety Tube Holder | Greiner Bio-One Vacuette North America | 2003 | — |
| 0 (this device) | K072320 | Greiner Vacuette Quickshield Complete | Greiner Bio-One North America, Inc. | 2007 | — |
| +1 | K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033478 | Vacuette Quickshield Safety Tube HolderSummary page 1…lood Collection Tube Holder Classification Name: Needle, Hypodermic, Single Lumen PREDICATE DEVICE: Greiner VACUETTE® QUICKSHIELD safety holder - K033478; VACUIETTE®) Multi-Sample Needles - K973620; VACUETTE® VISIO PLUS Needles - K061483 DEVICE DESCRIPTION: Intended… | 2003 |
| * | K973620 | Vacuette Multi-Sample NeedleSummary page 1…Needle, Hypodermic, Single Lumen PREDICATE DEVICE: Greiner VACUETTE® QUICKSHIELD safety holder - K033478; VACUIETTE®) Multi-Sample Needles - K973620; VACUETTE® VISIO PLUS Needles - K061483 DEVICE DESCRIPTION: Intended Use: The QUICKSHIELD Complete is intended to be… | 1997 |
| * | K061483 | Vacuette Visio Plus Blood Collection NeedlesSummary page 1…Lumen PREDICATE DEVICE: Greiner VACUETTE® QUICKSHIELD safety holder - K033478; VACUIETTE®) Multi-Sample Needles - K973620; VACUETTE® VISIO PLUS Needles - K061483 DEVICE DESCRIPTION: Intended Use: The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collectio… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2012 | Class II | Z-1935-2012 | Process control | : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K233979 (Greiner Bio-One North America, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033478.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO…
Read the full statement (130 words)
The QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is to be used by properly trained healthcare professionals only in accordance with these instructions. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Blood Collection Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072320 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072320: Greiner Vacuette Quickshield Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072320
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026